AB0983 RESULTS OF A PROSPECTIVE 6-YEAR OBSERVATIONAL STUDY OF THE EFFICACY AND SAFETY OF A BIOACTIVE CONCENTRATE OF SMALL MARINE FISH IN SENILE PATIENTS WITH KNEE OSTEOARTHRITIS AND MULTIMORBIDITY
Authors: T. Raskina, J. Averkieva, M. Letaeva, O. Malyshenko, M. Koroleva
Journal: Annals of the Rheumatic Diseases (2022)

Background According to the updated ESCEO, 2019 guidelines for the management of the knee osteoarthritis (OA), SYSADOA, which includes bioactive concentrate small sea fish (BCSSF), is a mandatory component of OA therapy. There are few studies evaluating the efficacy and safety of BCSSF in elderly patients with knee OA and a high level of multimorbidity, which served as the basis for this work. Objectives To evaluate the efficacy and safety of BCSSF therapy in elderly patients (75–90 years old) with knee osteoarthritis (OA) and multimorbidity based on the results of a prospective 6-year follow-up. Methods The study included 38 elderly women with OA of the knee (according to the criteria of ACR, 1986) stage II-III according to Kellgren-Lawrence, with pain ≥40 mm on the visual analog scale (VAS), who needed non-steroidal anti-inflammatory drugs (NSAIDs). BCSSF was administered as 1 ml intramuscular injections 20 consecutive days with a 6-month interval (12 courses). The impact of comorbidity on long-term prognosis was assessed using the Charlson comorbidity index. The effectiveness of therapy was assessed by VAS and WOMAC index. All patients during V0, V4 (36 months), V5 (72 months) underwent radiography of the knee joint. The safety of therapy was monitored throughout the observation period. The duration of the study was 6 years, the number of visits (V) - 6: V0 - day 1 (inclusion in the study and initiation of therapy); V1 - 21st day of therapy, V2, V3, V4, V5 - 12, 24, 36 and 72 months after the start of treatment, respectively. Results The 29 (76.3%) patients completed the full course of BCSSF treatment. 9 (23.7%) patients withdrew from the study due to the inability to visit the treatment site (for reasons not related to the study). Elderly patients with OA of the knee showed a high level of multimorbidity - an average of 5 comorbidities. The prognosis of 10-year mortality according to the Charlson index was 1–2 points (26%) in 2 (5.3%) patients, 3–4 points (52%) in 26 (68.4%) patients, ≥5 points (85 %) - in 10 (26.3%) respectively. There was a significant decrease in pain according to VAS (≥20%): by V1 - in 76.3%, by V2 - in 71.0%, by V3 - in 68.4%, by V4 - in 63.1% and V5 - in 55.2% of patients. There was a significant decrease in the total WOMAC index at all visits compared with baseline: V0 - 1125±135.0 mm, V1 - 647±229.0 mm, V2 - 642±224.0 mm, V3 - 594±216.0 mm, VB4 - 609±183.0 mm, V5 - 669±141.0 mm (р≤0.001 for all cases). The reduction in OA symptoms resulted in a significant reduction in the need for NSAIDs. By V1, 31.6% of patients refused to take NSAIDs, by V2 - 47.4%, by V3 - 44.7%, by V4 - 50.0% and by V5 - 44.7%. After 12 months of therapy, the number of days of taking NSAIDs significantly decreased to 5 (0; 10) days per month versus 14 (7; 15) days per month at the beginning of the study (p = 0.005). This rate remained relatively stable throughout the follow-up. X-ray progression of OA ≥1 stage according to Kellgren-Lawrence during BCSSF therapy after 36 months was recorded in 10.5% of patients, after 72 months - in 50.0%. During the entire period of observation, no serious adverse events were registered, including new cardiovascular accidents and allergic reactions. Conclusion The results of a 6-year prospective study demonstrate the high efficacy and safety of BCSSF in elderly patients with knee OA and high multimorbidity. Disclosure of Interests None declared